Joline GmbH & Co. KG
DE-MF-000005494 · Germany · Hechingen
Joline GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class I | 2 |
Among these devices, 8 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | JOLINE GMBH & CO. KG (DE) · FDA 3004734264 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
50565-61-A3-00 | reissued | 2030-11-29 |
50565-61-A2 | amended | 2025-11-29 |